Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes (SAMBA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Metabolic Fitness Association, Italy
Sponsor:
Collaborator:
University of Roma La Sapienza
Information provided by (Responsible Party):
Giuseppe Pugliese, Metabolic Fitness Association, Italy
ClinicalTrials.gov Identifier:
NCT01600924
First received: May 16, 2012
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

This project will assess the independent predictors of impaired muscle and bone strength through a longitudinal observation of a cohort of subjects with type 1 and 2 diabetes consecutively attending an outpatients diabetes clinics for the annual screening of complications.


Condition
Type 1 Diabetes
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes

Resource links provided by NLM:


Further study details as provided by Metabolic Fitness Association, Italy:

Primary Outcome Measures:
  • Independent predictors of reduced muscle and bone strength [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Baseline parameters predicting reduction of muscle and bone strength


Secondary Outcome Measures:
  • Relation of changes in predictors with reduced muscle and bone strength [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Relation of changes over time in predictors with reduced muscle and bone strength


Biospecimen Retention:   Samples Without DNA

Whole blood, plasma, serum and urine samples


Estimated Enrollment: 500
Study Start Date: October 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Outpatients clinics

Criteria

Inclusion Criteria:

  • Patients with type 1 or 2 diabetes

Exclusion Criteria:

  • Patients with any condition precluding mobility
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600924

Contacts
Contact: Giuseppe Pugliese, MD, PhD +39 06 33775440 giuseppe.pugliese@uniroma1.it

Locations
Italy
University of Rome La Sapienza, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Diabetes Unit Recruiting
Rome, RM, Italy, 00189
Contact: Laura Salvi, MD    +39 0633775249    adamas83@hotmail.it   
Sub-Investigator: Laura Salvi, MD         
Sponsors and Collaborators
Metabolic Fitness Association, Italy
University of Roma La Sapienza
Investigators
Study Director: Stefano Balducci, MD Sant'Andrea Hospital, Diabetes Unit
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giuseppe Pugliese, MD, PhD, Metabolic Fitness Association, Italy
ClinicalTrials.gov Identifier: NCT01600924     History of Changes
Other Study ID Numbers: MFA-12-02
Study First Received: May 16, 2012
Last Updated: October 10, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Metabolic Fitness Association, Italy:
diabetes mellitus
muscle strength
bone strength
cardiovascular risk factors
diabetic complications

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014